Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1. [ Time Frame: 24 weeks ]

The primary objective of this study was to compare the proportion of patients achieving biochemical control (defined as mean GH levels <2.5 µg/L and normalization of sex- and age- adjusted IGF-1) at 24 weeks with pasireotide LAR 40 mg and pasireotide LAR 60 mg separately versus continued treatment with octreotide LAR 30 mg or lanreotide autogel (ATG) 120 mg. The primary efficacy variable is the proportion of patients with a reduction of mean GH levels to < 2.5 µg/L and normalization of sex- and age-adjusted IGF-1 at 24 weeks.

The key secondary objective is to compare the effect of pasireotide LAR (40 mg and 60 mg separately) versus continuing the same treatment on the proportion of patients achieving normalization of sex- and age-adjusted IGF-1 at 24 weeks. The endpoint for the key secondary objective is the proportion of patients achieving normalization of sex- and age-adjusted IGF-1 at 24 weeks.

If a patient is randomized to the open label arm the investigator will either:

be instructed to contact a Novartis delegate to initiate shipment of either octreotide LAR 30 mg or lanreotide ATG 120 mg from a Novartis or designee depot to the site, or

continue to dispense either octreotide LAR 30 mg or lanreotide ATG 120 mg available at the institution to the patient if permitted by local regulations.

Drug: octreotide LAR 30mg

In an open-label, active control arm, continue on the same treatment with octreotide LAR 30 mg every 28 ± 2 days as received for at least 6 months prior to randomization

Drug: lanreotide ATG 120mg

In an open-label, active control arm, continue on the same treatment with lanreotide ATG 120 mg every 28 ± 2 days as received for at least 6 months prior to randomization

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients with written informed consent prior to any study related activity

Patients with inadequately controlled acromegaly as defined by a mean GH concentration of a 5-point profile over a 2-hour period > 2.5 µg/L and sex- and age-adjusted IGF-1 > 1.3 x upper limit of normal (ULN)

Patients treated with maximum indicated doses of octreotide LAR or lanreotide ATG for at least 6 months prior to visit 1 (screening). The maximum indicated dose for octreotide LAR is 30mg and for lanreotide ATG is 120 mg

Patients with diagnosis of pituitary micro- or macro adenoma. Patients can have been previously submitted to surgery

Exclusion Criteria:

Patients who have received pasireotide (SOM 230) prior to enrolment

Concomitant treatment with Growth Hormone Receptor (GHR)-antagonist or dopamine agonists unless concomitant treatment was discontinued 8 weeks prior to visit 1 (screening)(8 weeks wash out period). Such patients must have been treated with octreotide LAR 30 mg or lanreotide ATG 120 mg monotherapy continuously for a minimum of 6 months prior to starting combination therapy and they should have been inadequately controlled on monotherapy.

Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression

Patients who have received pituitary irradiation within 10 years prior to visit 1 (screening).

Patients who have undergone major surgery/surgical therapy for any cause within 4 weeks prior to visit 1 (screening).

Patients who are hypothyroid and not adequately treated with a stable dose of thyroid hormone replacement therapy

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137682